Unquantifiable Risk
Every year, the Medicine and Theater Selective makes creative and critical/analytical inquiry into subject matter involving the ethical dimensions of physician/patient interaction. The over-arching premise of the Selective is that the work of making theater can also be a unique means of probing the moral ambiguities that characterize ethical issues, particularly when its processes are informed not only by the imagination but also by intellectual rigour, and careful attention to the difference between art and propaganda. This year (Fall 1997), the field of inquiry has been xenotransplantation. Inspired chiefly by events and arguments surrounding a 1995 baboon bone marrow transplant to an HIV infected patient, the Selective, during a semester's discussion, research and analysis, created "Unquantifiable Risk," a work which invites reflection on a range of issues provoked by such aggressive and radical healing intervention: beneficence versus ambition; research versus therapy; resource allocation; the corporate partnership-healthcare institution equation; and the value and meaning of risk assessment, all in the context of the inherently fiduciary nature of the physician/patient-research subject relationship.
CHARACTERS
NARRATOR
DR. GIPP EDWARDS, a transplant surgeon and xenograft researcher.
DR. MAUREEN BENJAMIN, CEO, Benjamin Healthcare Technologies.
HARLEY SMOOT, an indigent, 34 year-old xenograft candidate.
DR. TAMARA REGAN, medical ethicist; member of Walter Grey Hospital IRB.
DR. MONROE BARNES, a cardiovascular physiology researcher; member of the Walter Grey Hospital IRB.
DR.JANE ALLEN, infectious disease specialist and AIDS researcher; member of Walter Grey Hospital IRB.
STEPHANIE SMITH, a 17-year-old xenograft candidate.
DR. ROSEMARY DEAS, Hospital Administrator, Walter Grey Hospital.
ALEXIA COLBY, a fabulously wealthy xenograft candidate.
RICHARD FABER, a 65-year-old xenograft candidate.
SCENE 1
NARRATOR: Drs. Benjamin and Edwards discuss the project.
DR. EDWARDS: Hey Maureen, how are you doing today?
DR. BENJAMIN: Fine; I just wanted to touch base with you about the project.
DR. EDWARDS: I'm glad you asked. Jane Allen from Infectious Disease has been making a lot of waves about retroviruses and what-not; but I think it's just a matter of smoothing out the wrinkles.
DR. BENJAMIN: Do you think she has a lot of support?
DR. EDWARDS: Well, right now it's token opposition; but it definitely could delay the project. Maybe she would think differently if she were waiting on the transplant list.
DR. BENJAMIN: Well, I haven't seen Rosemary in a while; so maybe I'll stop by and make sure we still have her support. How's the patient recruitment coming?
DR. EDWARDS: I have four likely candidates. I plan to speak with each of them today.
DR. BENJAMIN: Does anyone in particular stand out?
DR. EDWARDS: I hope that this 17-year-old girl will be a player for us. She's probably the healthiest! Her parents are receptive, but I think she is really apprehensive.
DR. BENJAMIN: If that doesn't work out, how do the other patients look?
DR. EDWARDS: I don't think we can go wrong. [Beeper goes off] Let me know how it goes with Rosemary.
DR. BENJAMIN: All right.
SCENE 2
NARRATOR: Dr. Edwards visits with xenograft candidate Harley Smoot. Smoot is a 34-year-old unemployed construction worker who is a rehabilitated I.V. drug user since 1992. He currently is suffering from a chronic bacterial endocarditis affecting multiple heart valves, and desperately needs a new heart.
DR. EDWARDS: Hello, Mr. Smoot. The nurse paged me; how are we doing today?
MR. SMOOT: I'm startin' to like this place. The food's all right; and I caught three basketball games last night.
DR. EDWARDS: Did the Bulls win last night?
MR. SMOOT: Yeah –the Hornets had 'em by two, but my man Jordan hit a threepointer with seven seconds left…. But enough about basketball, Doc. I've been thinkin' about what we talked about the other day, and I think I'll go with the pig heart instead of trying to wait for a real one. I know I'm pretty sick and I don't think I'll make it too long. The only thing is, I don't got any money.
DR. EDWARDS: We can find ways to handle the cost.
MR. SMOOT: You mean I ain't gotta pay for a thing?
DR. EDWARDS: No, that will all be taken care of. Because this is an experimental procedure, we have funding that will provide care for you.
MR. SMOOT: Can you put an animal heart in me and make it work? I ain't gonna start oinking and shit am I?
DR. EDWARDS: I believe my procedure can help you. But right now I need you to relax and not get excited when your Bulls get beat by my Knicks.
MR. SMOOT: Shiiiit—my Bulls are going all the way.
SCENE 3
NARRATOR: Three members of the Institutional Review Board (IRB) are sitting together in the Walter Grey Hospital cafeteria—Dr. Monroe Barnes, a cardiovascular physiology researcher; Dr. Tamara Regan, a medical ethicist; and Dr. Jane Allen, an infectious disease specialist and AIDS researcher. Previously, Dr. Edwards had submitted a proposal to the IRB that was returned to him as a "CONDITIONAL APPROVAL." The topic of this informal gathering is to discuss the resubmission of Dr. Edwards' xenograft transplant proposal with the newly revised criteria.
DR. REGAN: What do you guys think about this? I mean, a pig heart in a person?
DR. BARNES: As a cardiovascular physiologist, I think it's an excellent idea. It could save countless lives.
DR. ALLEN: But we need to think about the repercussions—if an unknown disease is unleashed on the population, it could be more deadly than AIDS. From a public health standpoint, there is too much at stake!
DR. BARNES: I understand your concern; however, I feel the academic benefits definitely outweigh the potontial harm. Think about what this could mean to science.
DR. REGAN: Science??? So, this is all about Dr. Edwards' career, isn't it? At least he's using a pig and not a poor baboon. I definitely would not agree with using a primate to promote his career; but there are still some troubling ethical concerns.
DR. ALLEN: To hell with the ethics. There has already been a retrovirus identified in porcine tissue, for God's sake! And in multiple copies, no less. We've got to do some serious characterization of this thing before we even consider introducing it into a human being.
DR. BARNES: You know, Jane, you're right. There's always a risk. However, no one has been able to quantify how large the risk is. Therefore, I think it would be in everyone's best interest to move forward in the name of saving lives.
DR. REGAN: Is it eternal life we're after? We're spending 14% of our GNP on health care, and millions of Americans still don't have access to primary care. With 5.5 billion people on the planet, should we be rebuilding dying humans with healthy animal parts?
DR. BARNES: Well, Dr. Regan, you haven't had any problems with human-to-human transplants; so why are you making such a big deal about xenotransplantation—which could potentially eliminate the side effects of immunosuppression and rejection with genetically engineered animals.
DR. REGAN: It's true—the genie is out of the bottle. Our grandmothers and closest friends have benefited from these technologies. But with scarce resources in an ever-exploding population, we need to decide what wishes we wanted the genie to grant in the first place.
DR. ALLEN: But there's still the issue of the retroviruses. We have no idea of their potential pathogenicity in humans. In fact, researchers have already found that a single pass of this retrovirus in tissue culture produces an infectious virus resistant to complement. That's our first line of defense! Gone!
DR. BARNES: In vitro. Not in vivo. No one knows what happens in vivo. There is no test that will prove it's 100% safe. To stop progress in the name of unquantifiable risk is ludicrous. People have been working with and eating
swine for centuries without documented disease transmission.
DR. ALLEN: That we know of.
DR. REGAN: I can see we're getting nowhere.
DR. BARNES: And neither will research if we listen to the two of you.
SCENE 4
NARRATOR: Dr. Edwards meets with his favorite transplant candidate. Stephanie Smith is a 17-year-old senior in high school, who plays basketball and is an honor roll student. She is suffering from viral myocarditis.
DR. EDWARDS: Hey, Sweetheart, how are you doing?
MS. SMITH: I don't know; you're not going to give me another shot, are you?
DR. EDWARDS: No, no, Stephanie—no more shots today. You must be a popular girl—those sure are beautiful flowers.
MS. SMITH: Yeah, my boyfriend got me those roses. My basketball team sent me the tulips. But my favorite ones are the ones over there that my dad got me. Did you see my parents out in the lobby?
DR. EDWARDS: Yes, Stephanie. I just got done talking with them, and they seem to feel confident in the surgery; but I wanted to see how you're feeling about things.
MS.SMITH Well, I know I need a heart. And I know that it would be a long wait for a human heart. But I am not sure how I feel about walking around with a pig's heart!
DR. EDWARDS: Well, I know it may sound crazy to be putting a pig's heart into you; but you would be amazed at how similar the two hearts actually are. In fact, we've been using animal parts for many years; especially pig heart valves.
MS. SMITH: Is it going to beat as long as the human heart would?
DR. EDWARDS: We really don't know; because it is a brand new procedure. [Pause.] You know Stephanie, ultimately, the decision is yours.
MS. SMITH: Will I be able to make it to the prom? [sniff, sniff.]
DR. EDWARDS: Stephanie, my job is to do everything in my power to make sure that you make it to your prom. This is the best option for you. I believe my procedure can help you.
SCENE 5
NARRATOR: Rosemary Deas, MD, MBA, Walter Grey's Hospital Administrator, is meeting in her office with her long-time friend and colleague, Maureen Benjamin, MD, DVM, MBA. Dr. Benjamin is the CEO of Benjamin Healthcare Technologies, which is the supplier of Dr. Edwards' porcine organs; and partially funds Dr. Edwards' xenograft research. For the last 15 years, this company has been involved in a number of experiments at the hospital. The company's success has been in antimicrobial therapy, pacemaker technology, and genetic engineering.
DR. DEAS: Hey Maureen, come on in.
DR. BENJAMIN: Hi, it's good to see you. Thanks for taking the time to meet with me.
DR. DEAS: No problem. How have you been? I've missed seeing you at soccer practice this year.
DR. BENJAMIN: Well, Jason decided to play football this year. Well, anyway, I am sure you know that my company is working with Dr. Edwards on the xenotransplantation trial. I've heard it's been meeting some resistance from your ID folks.
DR. DEAS: Yeah. Dr. Allen from 10 has been voicing concern over the possibility of porcine retroviruses; and Dr. Edwards told me that she has been putting pressure on his transplant team recently.
DR. BENJAMIN: Well, let me give you the rundown: One class of endogenous porcine retrovirus has been described. However, thanks to genetic engineering, we have worked out a means to block its expression in our products. We have incorporated a ribozyme into the porcine genome that digests PERV RNA, preventing viral expression. About the issue of other endogenous retroviruses, we find no evidence to suggest the existence of such viruses. We have used RNA primers to search the entire porcine genome for transcriptionally active retroviral agents; and are confident that no such agents exist in our products. Even if something were to exist, the risk of anything harmful happening is really insignificant.
DR. DEAS: So, with the molecular technology to test for and eliminate any retroviruses, it seems like there is not much risk.
DR. BENJAMIN: The risk is minimal, and I am confident that we've taken the necessary precautions to be able to proceed with trials at this time.
DR. DEAS: Well, great. I am getting really excited about our partnership. I think it will be a real success.
DR. BENJAMIN: We will meet future obstacles; but, hopefully, together we can have a real impact on the field of transplantation. I'm going to leave these articles with you. If you have any questions in the future, just give me a call anytime.
DR. DEAS: Okay, I will. Thanks for stopping by.
DR. BENJAMIN: It was great to see you.
SCENE 6
NARRATOR: Dr. Edwards meets with Alexia Colby, who is a famous heiress and, a major contributor to Walter Grey Hospital. The cancer research center has been named in her honor. She prefers the human organ transplant, but Dr. Edwards raises the alternative of "bridging." Using the porcine heart will allow her more time to await a human heart. She has, an abnormal/dysfunctional pericardium as a result of radiation treatment twelve years ago for Hodgkin's Disease.
MS. COLBY: Hey, Doc, I’m glad you stopped in. I’ve had my personal assistant doing some research on this procedure, and I am not really sold on it. I’ll feel more comfortable waiting on a human heart.
DR EDWARDS: I can appreciate your concern, Alexia. But the longer you wait for a human heart, the greater the risk of complications; and looking at your numbers, time is of the essence.
MS. COLBY: Listen, I’ve pulled a few strings and I am pretty sure that I am high on the transplant list.
DR EDWARDS: While you may be high on the list, realistically you might have to wait years; and I’m concerned that your heart isn’t going to make it. This bridge therapy is your best alternative while waiting for a match.